21 CFR Part 11 Compliance

For customers working in an environment regulated by the FDA, it is necessary that software be compliant with regulations adopted by the FDA. These regulations are contained in the Code of Federal Regulations (CFR), Title 21, Part 11, and are entitled "Electronic Records; Electronic Signatures". The rules change significantly how computer-generated data is to be stored and used, and aim to make electronic records comparable to a lab notebook in terms of providing a traceable record that is immutable.

In order to comply with the strict demands of 21 CFR Part 11, Wyatt Technology Corporation has designed its main software product, ASTRA, from the ground up to comply. In addition, the ASTRA software has been developed under a formal quality system to ensure that the software is completely validatable. Wyatt Technology Corporation welcomes audits by qualified personnel to verify that we have met the requirements of 21 CFR Part 11.

For essential macromolecular and nanoparticle characterization—The Solution is Light™

Need more information?

Resources

Wyatt Technology is the recognized leader in light scattering instrumentation and software for determining the absolute molar mass, size, charge and interactions of macromolecules and nanoparticles in solution.